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David P Elder Consultancy
4 January 2018 | By David Elder (JPAG member and consultant)
Microbiological contamination of non-sterile medicinal products is an infrequent, but longstanding and recurring issue. But there is no ‘one size fits all’ approach towards objectionable organisms, says David Elder...
Particle size reduction is a fast and cost-effective answer to increasing the exposure of poorly soluble oral drugs by increasing surface area and thereby improving dissolution rate. This approach will only work for DCS IIa1 drugs where dissolution rate is the rate-limiting factor for absorption. This may be applicable to…
When the United States Food and Drug Administration (FDA) called for a shakeup of pharmaceutical production in 2002 it recommended the early adoption of technological advances and the application of modern quality management techniques. It believed that this would make manufacturing processes more robust and improve product quality.1
2 November 2017 | By Dave Elder
The EMA recently introduced labelling requirements for some common excipients based on an in-depth assessment of their safety profiles, particularly in the paediatric population.1 This article considers their use in multidose products...
25 October 2017 | By Dave Elder
Film coating is a common step in tablet manufacture that can be used to improve product appearance, organoleptic properties, or to facilitate swallowing. Functional film coats can also be used as a part of the product’s stabilisation strategy and to modify or delay drug release.
23 October 2017 | By European Pharmaceutical Review
In this issue Dave Elder discusses issues around the manufacture of film coatings and Adeyinka Aina and colleagues consider the potential medicinal uses and efficacy of the flavonoids epigallocatechin and epicatechin, which can be extracted from the Spondias mombin plant.
3 July 2017 | By European Pharmaceutical Review
In this Separations & Purifications In-Depth Focus: Experts from Leo Pharma explain how they use an MHC 2D-LC system in their analytical troubleshooting laboratory and how it can be applied to solve key tasks in the lab. Plus, Dave Elder explains how guidance for mutagenic impurities has necessitated control of…